Trial · NCT00145158
Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma
NCT00145158, Phase 1, Phase 2, Terminated, Ludwig Institute for Cancer Research; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma. Trials, record NCT00145158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00145158
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma
- NCT number
- NCT00145158
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Ludwig Institute for Cancer Research
- Conditions
- Malignant Melanoma
- Interventions
- 8 HLA-A2-restricted peptides and Montanide ISA51, 8 HLA-A2-restricted peptides and CpG 7909
- First posted
- 2005-09-05
- Last updated
- 2022-10-10
- Results first posted
- 2022-04-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. | Week 13 | Peripheral blood lymphocytes (PBL) were collected prior to the first dose of vaccine and after the completion of the six vaccinations in Week 13. Specific CTL directed against the 8 vaccine antigens ( NA17.A2, MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 and Tyrosinase.A2) was assessed by using re-stimulation in vitro, followed by staining with the corresponding tetramer (MLPC/tetramer). A patient was considered to have a positive CTL response when the post-vaccine CTL response against at least one of the vaccine antigens was ten times higher than the corresponding pre-treatment value. |
| Secondary | Number of Patients With Dose Limiting Toxicities (DLT). | up to Week 13 | Toxicity was evaluated according to the National Cancer Institute (CTC Scale Version 3.0, published December 12, 2003). Dose limiting toxicity (DLT) is defined as: * Any Grade 3 hematological or non-hematological toxicity other than skin or flu-like symptoms * Any Grade 4 toxicity To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent. |
| Secondary | Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. | Week 13 | Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor measurements were taken at screening and at the end of Cycle 1 in Week 13. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. |
| Secondary | Number of Patients With Cytotoxic T-lymphocyte (CTL) Responses and Tumor Expression of the Corresponding Genes. | Week 13 | Gene expression was determined by RT-PCR on a pre-treatment tumor sample. The correlation of the induction of a CTL response against a defined antigen to the prior expression of the gene coding for this antigen by the tumor removed before vaccination was assessed. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. | Week 13 | Patients who received at least six vaccinations and had samples taken at Week 13. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Dose Limiting Toxicities (DLT). | up to Week 13 | All patients who received at least one immunization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. | Week 13 | Patients who received at least six immunizations and had tumor response measured at Week 13. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Cytotoxic T-lymphocyte (CTL) Responses and Tumor Expression of the Corresponding Genes. | Week 13 | Patients who had pretreatment tumor samples analyzed for gene expression, received at least six immunizations and had CTL responses at Week 13. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | Patients with CTL Response | 6 | Participants | |
| Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | Patients with CTL Response | 1 | Participants | |
| Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | Patients with no CTL Response | 8 | Participants | |
| Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | Patients with no CTL Response | 2 | Participants | |
| Number of Patients With Dose Limiting Toxicities (DLT). | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 2 | Participants | ||
| Number of Patients With Dose Limiting Toxicities (DLT). | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 0 | Participants | ||
| Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | Complete Response (CR) | 0 | Participants | |
| Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | Complete Response (CR) | 0 | Participants | |
| Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | Partial Response (PR) | 0 | Participants | |
| Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | Partial Response (PR) | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 16 | |
| Overall Study | STARTED | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 7 | |
| Overall Study | COMPLETED | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 14 | |
| Overall Study | COMPLETED | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 4 | |
| Overall Study | NOT COMPLETED | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 2 | |
| Overall Study | NOT COMPLETED | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 3 |
Source ClinicalTrials.gov
Adverse events244
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 16 | 16 | |
| other | Injection site erythema | General disorders | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 6 | 7 | |
| other | Injection site pain | General disorders | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 14 | 16 | |
| other | Injection site pain | General disorders | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 2 | 7 | |
| other | Injection site induration | General disorders | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 11 | 16 | |
| other | Injection site induration | General disorders | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 2 | 7 | |
| other | Fatigue | General disorders | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 8 | 16 | |
| other | Fatigue | General disorders | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 3 | 7 | |
| other | Pyrexia | General disorders | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 9 | 16 | |
| other | Pyrexia | General disorders | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 1 | 7 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 0 | 16 |
| Total, all-cause mortality | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 0 | 7 |
| Total, other adverse events | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 16 | 16 |
| Total, other adverse events | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 7 | 7 |
| Total, serious adverse events | Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 | 7 | 16 |
| Total, serious adverse events | Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 | 3 | 7 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 vs Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51: Number of Patients With Cytotoxic T-lymphocyte (CTL) Responses and Tumor Expression of the Corresponding Genes. | Trial comparisons |
| Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 vs Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51: Number of Patients With Dose Limiting Toxicities (DLT). | Trial comparisons |
| Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 vs Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51: deaths from any cause | Trial comparisons |
| Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 vs Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00145158
GET https://conductscience.org/api/trials/v1/NCT00145158/events?page=2